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NCT03382964 · ClinicalTrials.gov registry record · Phase 1
Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers
A Phase 1 study, sponsored by Valneva Austria.
- Completed
- Registry status
- Phase 1
- Development phase
- 120
- Enrollment target
NCT03382964: Completed Phase 1 study, sponsored by Valneva Austria.
NCT03382964 is a Phase 1 study that has completed, run by Valneva Austria. The registered enrollment target is 120 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03382964, a Phase 1 study, has completed, sponsored by Valneva Austria.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 120 participants
- Enrollment target
Study Summary
Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization. 120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the high dose group). Vaccination will be given intramuscularly on Day 0. As safety precaution, the study will begin with enrolment of 20 sentinel subjects in an open-label fashion. Thereafter, subjects will be enrolled in a blinded, randomized manner in the three study arms. A re-vaccination will be given at Month 6 or Month 12 to confirm that a single vaccination will be sufficient to induce high titer neutralizing antibodies and protect subjects from CHIKV viremia. Study participants will be followed up until 13 months after initial vaccination.
Primary Outcome
Any measurable injection site reaction will be measured by size and includes injection site pain, tenderness, erythema/redness, induration and swelling.
Interventions
- BIOLOGICAL VLA1553
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 120 participants |
| Start Date | 2018-03-05 |
| Est. Completion | 2019-07-28 |
| Phase | Phase 1 |
What the finished NCT03382964 record still lists
NCT03382964 is an interventional study that assigns participants to a tested intervention. The registered 120 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (100% higher).
The record links to 0 conditions, and to 1 intervention - of which VLA1553 is the first listed.
NCT03382964 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03382964 about?
NCT03382964 is a clinical study titled "Study to Assess the Safety and Immunogenicity of a Chikungunya Virus Vaccine Candidate (VLA1553) in Healthy Volunteers". Randomized, observer-blinded, multicenter, dose-escalation Phase 1 clinical study investigating three dose levels of VLA1553 after a single immunization. 120 study participants will be enrolled into the study to receive three different doses (30 subjects in the low and medium and 60 subjects in the...
What is the current status of trial NCT03382964?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 120 participants. The study started on 2018-03-05. Estimated completion is 2019-07-28.
What interventions are being tested in trial NCT03382964?
The interventions under investigation include: VLA1553 (BIOLOGICAL).
Who is sponsoring clinical trial NCT03382964?
This trial is sponsored by Valneva Austria, which has 11 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03382964's enrollment target sits among peer trials
120 479th of 2000 higher than 1,503 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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